FDA Finds Flaws In Theranos' Zika Tests (techcrunch.com) 74
An anonymous reader quotes a report from TechCrunch: This past week, the U.S. Food and Drug Administration mandated testing for the Zika virus at all U.S. blood centers. That juices demand for Zika-testing technology, but one company that isn't welcome to provide it yet is Theranos. The beleaguered blood analysis startup has run afoul of the FDA, yet again, The Wall Street Journal reports (Warning: may be paywalled). Specifically, regulators found that in developing and testing a new Zika-diagnostic technology, Theranos failed to use proper patient safety protocols, the type approved by an institutional review board. Such protocols are critical in ensuring the ethical treatment of patients involved in studies, and their safety. Theranos had sought the same FDA authorization, but voluntarily withdrew its request once regulators called the startup out, this time, on the safety protocols issue.
Girl Power! (Score:5, Insightful)
How much of the hype behind this company centered on the fact that its leader was a young, attractive, blonde woman from Stanford?
How much actually focused on the product and the likelihood of it succeeding?
Our news today is more entertainment than fact.
Re: (Score:2)
Just saying, I wouldn't need a bag over her head to finish the job.
Uh-huh. What about a bag over yours?
Re: (Score:2)
Re:Girl Power! (Score:5, Interesting)
Easily, I'd imagine. If the tests are inaccurate or are improperly performed, people might unknowingly spread a disease, or undergo potentially dangerous treatment that they don't require. That's a serious enough consequence to require regulation.
Re: (Score:2)
How much of the hype behind this company centered on the fact that its leader was a young, attractive, blonde woman from Stanford?
In that vein, how much of the hate is centered on the same thing? Certainly less, I'm sure, but I'd wager you wouldn't see the same amount of vitriol if Theranos was helmed by some random CEO Joe. Unless it were Martin Shkreli, perhaps ... but that's a whole different sack of assholes.
Re: (Score:2, Funny)
So you pre-emptively void a counter-example to establish an ad hoc save of your grouping statement?
There's a phrase for that.
Re: (Score:2)
http://blogs.sciencemag.org/pipeline/archives/2007/11/06/andy_grove_rich_famous_smart_and_wrong
Software and hardware design always proceeds from highly predictable and well documented systems. Most things can be simulated from first principles, and unpredictable pieces of hardware are eliminated, either at the design stage or repla
A Vital Distinction (Score:1)
Insightful. I see this division all the time: some fields succumb to theory; others require a consequentialist outlook.
Re: (Score:2)
Because companies run by male CEOs never have ethical problems. No sirreee, we must look at companies run by women, their gender makes them suspect!
Re: (Score:1)
Re:Girl Power! (Score:4, Informative)
How much of the hype behind this company centered on the fact that its leader was a young, attractive, blonde woman from Stanford?
I would say not much. Theranos was promising drug tests that would be significantly cheaper than current tests. According to Theranos pricing, Basic Metabolic Panel for about $6 bucks, Lithium level for $5... Together those might cost $200 (without insurance). I couldn't give two shits about who is at the helm if that's what they're promising.
Re: (Score:1)
Do you care about accuracy? Because Theranos apparently doesn't and just makes shit up wholesale.
So if not - Let me save you hundreds or even thousands of dollars, and a painful blood draw! Just send me a dollar, the test you want, and your return address, and I'll send you back a random number for whatever test you've requested! Win-win, if price counts as your only consideration!
Re: (Score:3)
You Missed The Point (Score:1)
This was accepted because the attractive girl fits into one of our media tropes, the Girl Power! trope. It also fits into our Silicon Valley trope.
These tropes encourage us to believe that the unlikely is possible because that's the way it happens in movies. If Theranos had been helmed by an old white guy, there would have been media pushback, critical questions, etc.
Instead t
Re: (Score:2)
Do you care about accuracy?
Neither do venture capitalists! They seem to reckon everyone lies (they don't) and they they are smart enough to know by how much (they aren't). Their idea of due dilligence seems to be 6 months of arsing around followed by checking to see if anyone else has invested then joining the dogpile.
Oh an the dogpile is big because no one wants to lose face by not investing in the big winner that all their frenemies invested in.
Re: (Score:2)
Celebrities (Score:1)
At that point, we should just call them what they are: celebrities. Sort of like how people expect spiritual and political advice from rock stars and movie actors.
Re:Girl Power! (Score:4, Insightful)
How much of the hype behind this company centered on the fact that its leader was a young, attractive, blonde woman from Stanford?
How much actually focused on the product and the likelihood of it succeeding?
Our news today is more entertainment than fact.
Well at this point the primary story is the meta story about how otherwise sophisticated investors put in tons of money behind the the young, attractive, blonde woman even though they were shown very little evidence. That meta story is both entertaining and fact based.
Re: (Score:2)
Well at this point the primary story is the meta story about how otherwise sophisticated investors put in tons of money behind the the young, attractive, blonde woman even though they were shown very little evidence. That meta story is both entertaining and fact based.
The thing is with playing up the young, blonde part... where are all the stories about VCs putting vast amounts of money behind ordinary looking guys (as happens a lot) and losing it all because it was always a really stupid idea. The "young,
Re: (Score:2)
That sounds like the latest release from Fleshlight Inc.
A Blonde Herring (Score:1)
At least it's an organic offering from Fleshlight Inc.
Re: (Score:1)
How much of the hype behind this company centered on the fact that its leader was a young, attractive, blonde woman from Stanford?
Don't knock blondes, it's just everyone from Stanford that is a shiesty scammer with no morals or competence.
Elizabeth Holmes, Sexy Beast -- Or Not? (Score:1)
Great contribution. An alt right blogger expanded on this:
http://www.amerika.org/science... [amerika.org]
Which is the more realistic image? ...beats me, but the one on the left, I'd like to get her phone number.
Re: Girl Power! (Score:2)
Eh...you left out the part about her deciding, after one year at college, that the whole education thing was overrated and she should just go ahead and found Theranos. Despite not having any background in medicine, chemistry or biology.
Too "smart" for her own good.
"Smart" (Score:1)
There's a lot of "smart" (or perhaps clever) around today. Michael Crichton called it "thin intelligence."
Vanity Fair Gives A Thumbs-Up To This POV (Score:1)
How many times do you screw up... (Score:4, Informative)
...before you get the idea that you need to start doing things properly?
Theranos really don't seem to be getting the hint that if they want to be taken seriously now they need to be utterly scrupulous about everything they do.
Re: (Score:3, Insightful)
How many times does a company like this need to screw up before being forcibly shut down by the feds?
Embezzle a little money and they come in and lock the doors on any business you run. Endanger people's lives and you get a slap on the wrist. What's wrong with this picture?
captcha = "boners"
Re: (Score:2)
How many times does a company like this need to screw up before being forcibly shut down by the feds?
If the CEO was a man instead of the poster child for "women STEM CEOs," it would have been shut down a long time ago.
Re: (Score:2)
Elizabeth Holmes still pretending to be a grown up (Score:5, Funny)
Re: (Score:1)
I wonder how much longer it will take before people finally realize Theranos and Holmes are a scam.
No they didn't. (Score:1)
Nope. The FDA didn't find a thing wrong with the actual test.
The FDA found flaws in the process used to validate the test, and more specifically around the patient data privacy.
That has nothing to do with a judgement that the underlying test isn't effective.
Re: (Score:3)
If the validation was done wrong, then the test isn't valid until the validation is done right.
If the validation was done right but the patients' privacy was breached, fine them under HIPAA and if the company isn't bankrupt, let them do their testing.
Re:No they didn't. (Score:4, Interesting)
Re: (Score:2)
If their method works, but they violated the patient protocol, easy peasy. TAKE their approach, TAKE their capital (money and equipment) and tell their entire management staff they are out of biz, and further they are banned from any medical company for life. Now that would be incentive in the future for all medical companies to follow patient protocol.
Re: (Score:2)
So there's nothing wrong with the diagnostic ... (Score:5, Interesting)
... but the FDA is still finding something to complain about.
This is after preeminent scientists argue that bioethics needs to get out of the way [bostonglobe.com] of modern research.
An interesting parallel, by the way, was John Nestor. Here was a guy that intentionally (and even with good intention) drove 55MPH in the fast lane of DC traffic [washingtonpost.com]. He was, at best, misguided, since speed differential is more dangeous than speed [wikipedia.org] and his actions were likely safety-reducing. He was also an FDA bureaucrat that never approved a drug and was ultimately fired [jpands.org] for his "caution" that probably cost more lives and more lifesaving drugs than it ever saved.
There's something wrong with Theranos (Score:5, Interesting)
Re:So there's nothing wrong with the diagnostic .. (Score:5, Interesting)
... but the FDA is still finding something to complain about.
I can't see it say anywhere that the diagnostic test from Theranos works. It just says that there are problems with associated protocols. Seems like yet another example of their corner cutting behavior. Theranos doesn't exactly have a good history of producing reliable diagnostic tests.
Re: (Score:1)
Re: (Score:2)
What the FDA really needs to do is ease up on "me-too" products. The latest drug price scandals were not a result of drug patents, but because getting permission to sell something like an Epi-Pen takes a long time and is expensive. So, drug company A produces something, realizes it's got a monopoly, and raises the price a lot. Drug company B can take a year or three and spend lots of money and get permission to produce the same thing, and drug company A then drops the price to previous levels to hurt dr
Re: (Score:1)
Re: (Score:2)
Also, I think it was Abraham Lincoln who said(?) "The best way to get rid of an unjust law is to enforce it strictly."
Forcing others to abide by an unjust law as a form of civil disobedience in an attempt to get the law repealed is
In too deep (Score:1)
She started off iam sure with good intentions until she discovered it (their magic machine "Edison") doesnt actually work, by then she had enough funding to make her rich for life, she couldn't just stop and say sorry it doesn't work and hand the money back to investors she would be ruined, now she is in too deep to stop and so the charade continues until she is forced to stop.
shame peoples lives are at risk while it continues, much like Teslas "autopilot", how many innocent people have to die until you cal
I Thought They Were Banned (Score:1)
I thought Theranos had been banned form blood work. Why are they still in operation?
Re: (Score:2)
Re: (Score:2, Funny)
What the hell, headline writer? (Score:2)
There's nothing about the test being wrong. It' just that they ignored patient safety while conducting trials.
If you don't read the article, please don't write the headline.
They are trying to run big pharm (Score:2, Insightful)
These people are trying to run big pharm like it's a startup selling kitten mittens. Do it fast, get it to the market without proper testing and let our users beta test. It's all an internet scam, the only difference between Theranos and some other dot com blowout, is the government has more control over approval for medical treatments and devices.
Thernaos test fails FDA standards - which were low (Score:2)